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Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System

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ClinicalTrials.gov Identifier: NCT03680950
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

Brief Summary:
A monitoring system was developed for detecting upper gastrointestinal (UGI) rebleeding. This system consists of (1) a tiny endoscopy, (2) a wearable device, and (3) a software. The endoscopy is inserted to UGI tract via nasal cavity and then stayed there for 3 days. The wearable device is set to regularly receive the pictures from the endoscopy and sent to the software, which is able to automatically analyze whether the rebleeding occurs. This study aims to test the feasibility and efficacy of the monitoring system.

Condition or disease Intervention/treatment Phase
Upper Gastrointestinal Bleeding Device: Upper Gastrointestinal Monitoring System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System
Actual Study Start Date : October 12, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Upper Gastrointestinal Monitoring System
Participants who meet criteria of enrollment and is willing to join in this study will wear a real-time upper gastrointestinal monitoring system for checking whether upper gastrointestinal rebleeding occurs continuously for 3 days.
Device: Upper Gastrointestinal Monitoring System
Participants will wear a monitoring system consisting of a tiny endoscopy and a mobile device. The endoscopy is inserted to upper gastrointestinal tract via nasal cavity and the mobile device is set to take and send images from the endoscopy to a server for analyzing if the abnormal condition occurs.




Primary Outcome Measures :
  1. Time to detection of upper gastrointestinal rebleeding between the upper gastrointestinal monitoring system vs. the current monitoring index. [ Time Frame: 3 days ]
    The real-time upper gastrointestinal monitoring system is compared with the current monitoring index. The efficacy is estimated by which monitoring method finding the upper gastrointestinal rebleeding first.


Secondary Outcome Measures :
  1. The accuracy of upper gastrointestinal rebleeding detection between the upper gastrointestinal monitoring system vs. the current monitoring index. [ Time Frame: 3 days ]
    The accuracy of the current monitoring index and the real-time upper gastrointestinal monitoring system is compared. The accuracy is estimated by calculating the ratio of the number of making false alarm and the number of finding re-bleeding right.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • "Rockall" score ≧3

Exclusion Criteria:

  • Pregnant woman;
  • Behavioral disorder;
  • Major cognitive-perceptual deficit;
  • The person who has a nasogastric (NG) tube;
  • Other deficits or disorders that are not suitable for NG insertion;
  • Participants who need to take MRI scan.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680950


Contacts
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Contact: Chiao-Hsiung Chuang, MD 886-6-2353535 ext 2679 jasonc@mail.ncku.edu.tw

Locations
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Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Contact: Chiao-Hsiung Chuang, MD         
Sponsors and Collaborators
National Cheng-Kung University Hospital

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Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT03680950     History of Changes
Other Study ID Numbers: B-BR-106-096
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Hemorrhage
Pathologic Processes